CLAIMS
FOR STROKE RESULTING FROM PHENYLPROPANOLAMINE OR PPA IN OVER-THE-COUNTER
DIET DRUGS AND COLD MEDICATIONS

1. What is PPA?

Phenylpropanolamine ("fen-el-pro-pa-nol-a-mine" or "PPA") is an ingredient
used in many over-the-counter and prescription cough and cold medications
as a decongestant to relieve stuffy nose or sinus congestion and in
over-the-counter weight loss products.

PPA has been available for at least 53 years, if not longer. Americans
take 6 billion doses of the ingredient each year in a wide range of
prescription and over-the-counter products, including the popular brand
names Alka-Seltzer Cold, Bayer Cold, Dexatrim, Dimetapp, Robitussin-CF,
Dristan, Tavis-D, Allerest, Triaminic, Allergy Relief, Contac, and Sucrets
Cold. By some calculations there are as many as 400 over-the-counter
products containing PPA.

2. Adverse Events

A recent industry funded study conducted
by Yale University found that PPA increases the risk for hemorrhagic
stroke (bleeding into the brain or into tissue surrounding the brain).
The study included a long history of published serious adverse events,
including hemorrhagic stroke, attributed to PPA going back to 1979.
These cases were attributable to PPA because they typically occurred
close in time to ingestion of PPA in otherwise healthy younger people.
There was a lack of other plausible explanation for the occurrence of
these events in these younger individuals. In addition, PPA is known
to cause cerebral vasculitis, a severe inflammation of the blood vessels
in the brain, which in combination with the blood pressure raising effects
of PPA, can result in cerebral or subarachnoid brain hemorrhage and
stroke. Since the dangers of PPA were not previously known to the public,
it is highly likely that many such individuals who suffered hemorrhagic
stroke never associated this terrible event with their use of products
containing this drug. Further, even doctors and other medical personnel
may well have failed to make the connection between the stroke and PPA,
because they were unfamiliar with the dangers of the drug.

Symptoms include headache, nausea and stimulation. Other than stroke,
acute psychosis, convulsions, acute renal failure, heart damage and
hypertension have also been reported.

Though the Food and Drug Administration (FDA) has only 51 confirmed
reports of hemorrhagic stroke, analysts relying upon the Yale Study
now estimate that 200-500 strokes occurred per year in women age 18-49
due to PPA. It is well known that only a very small percentage of adverse
drug reactions are ever reported to the FDA. With estimates that the
percent of cases of over-the-counter adverse drug reactions that are
sent to the FDA are between 5% and 10% of those that actually occur,
this total of 51 reported cases of hemorrhagic stroke can mean as many
as 510 to 1020 cases have actually occurred in persons using PPA containing
products.

On November 6, 2000, in response to the Yale study, the FDA ordered
that all over-the-counter manufacturers remove PPA from their products.
The FDA determined that the conditions for which PPA is used did not
justify the risk of serious harm posed by the drug. The FDA concluded
that PPA "cannot be considered to be safe for continued use". (FDA
Talk Paper, 11/6/00) .

4. Population at Risk

The Yale study of patients at 43 hospitals found that women aged 18
to 49 who had taken appetite suppressants with PPA were 16 times more
likely to suffer a hemorrhagic stroke. There was no reason to believe
that men face a lower risk. Further, among men and women taking a cough
or cold remedy containing PPA for the first time, the risk of a stroke
was three times higher than normal.

5. Precautions

There are other available products on the market not containing PPA
that can fulfill the same role as the withdrawn products. Consumers
should ask their pharmacist or health care provider what other products
are available for their needs. Over-the-counter drug products containing
this ingredient may be identified by looking for "phenylpropanolamine"
in the list of active ingredients on the label. If a prescription nasal
decongestant or cough/cold product is being used, consumers should talk
to their pharmacist or health care provider to determine if PPA is present.
If you believe you have been injured by PPA please contact us at ppa@toxicdiscovery.com